- La tirbanibulina (KX01) è un nuovo inibitore della tirosina chinasi Src con una potente attività antiproliferativa sui cheratinociti, approvato per il trattamento delle cheratosi attiniche. Il presente studio di fase 1 ha indagato la sicurezza e l’attività di KX01 in unguento nei pazienti con psoriasi in placche.
- KX01 0,01, 0,1 e 1% sono risultati sicuri e ben tollerati.
- KX01 1% ha mostrato a 4 settimane un’azione promettente per il trattamento della psoriasi.
Plaque-type psoriasis is a common skin disorder. Tirbanibulin (KX01) is a new Src kinase inhibitor with potent antiproliferative activity against keratinocytes and has been approved for treatment of actinic keratosis. This Phase I study investigates the safety and activity of KX01 ointment in patients with plaque-type psoriasis. We recruited 28 patients from two medical centers in Taiwan. This study was performed in four stages. Double-blind treatments were randomized in stages I (KX01 0.01% + placebo, two rounds of two-week treatment) and II (KX01 0.1% + placebo, four weeks) and open-labelled in stages III (KX01 1%, five days) and IV (KX01 1%, five days weekly for four weeks). The safety, tolerability, KX01 concentration, target area score, physician global assessment, and disease relapse were determined. Most treatment-emergent adverse events were mild-to-moderate application site reactions. Three (50.0%) subjects from the stage IV group showed ≥50% reduction in the target area score (TAS50), while two subjects (33.3%) showed a clinically meaningful improvement in the physician global assessment score. KX01 0.01%, 0.1%, and 1% were safe and well-tolerated. KX01 1% at four weeks showed a promising activity for the treatment of plaque-type psoriasis.